Title: Effect of Ularitide on Cardiovascular Mortality in Acute Heart Failure

Packer, M. MD, et al.


What You Need to Know:

While the natriuretic peptide ularitide was found to exert favorable physiological effects in patients with acute heart failure, short-term treatment did not reduce long-term cardiovascular (CV) death, nor did it affect a clinical composite endpoint.

Trial Design:

  • Double-blind trial which included 2157 patients with acute heart failure
  • Patients randomized to receive ularitide 15ng/kg IV per minute or placebo for 48 hours
  • Treatment started a median 6hrs after initial clinical evaluation
  • Coprimary outcomes: death from CV causes during median follow-up of 15 months; composite endpoint that evaluated first 48hr clinical course

Key Outcomes:

  • Death from CV causes: 21.7% of ularitide group vs. 21.0% pf the placebo group; hazard ratio, 1.03; 96% confidence interval, 0.85–1.25; P=0.75)
  • Hierarchical composite outcome: no significant between-group difference
  • Greater reductions in systolic blood pressure and N-terminal pro-brain natriuretic peptide in ularitide group vs. placebo
  • In the 55% of patients with paired data, changes in cardiac troponin T levels did not differ between groups